Recurrent Colorectal CarcinomaPhase 2NCT03823079
Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia
A Phase 2 study testing rhTPO, irinotecan and Raltitrexed in people with Recurrent Colorectal Carcinoma and Thrombopenia, run by Fudan University.
Trial summary
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Colorectal Carcinoma, Thrombopenia
- What is being tested?
- rhTPO, irinotecan and Raltitrexed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary tumor is colorectal cancer, histologically proved recurrence or metastasis disease, or pelvic relapse within 6 months after oxaliplatin-based adjuvant chemotherapy.
- Not suitable for re-use of oxaliplatin and fluorouracil.
- No medication history of irinotecan.
- Lesions evaluable, and has indications for radiotherapy.
- UGT1A1*28 gene phenotype is 6/6 or 6/7
- Karnofsky physical condition score ≥ 70
Show all 9Show fewer
- Baseline platelet counts are 25-75×10^9/L, other bone marrow reserve and liver and kidney function meet the requirements of radiotherapy
- Able to follow the program during the study period
- Sign the informed consent
Who cannot join
- Pregnant or breastfeeding women
- Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- Anyone who is allergic to any research medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.
Read the detailed description
Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil. Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay. On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation. Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy. This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.
- Conditions
- Recurrent Colorectal Carcinoma, Thrombopenia
- Being tested
- rhTPO, irinotecan, Raltitrexed, radiotherapy, rhIL-11
- Keywords
- Recombinant human interleukin-11, Recombinant human thrombopoietin
- Medical subject headings
- Colorectal Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
rhTPO 300u/kg, subcutaneous injection, qd
irinotecanDrug
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
RaltitrexedDrug
3mg/m2 q3w
radiotherapyRadiation
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
rhIL-11Drug
rhIL-11 50ug/kg, subcutaneous injection, qd
| Study group | Role | What they receive |
|---|---|---|
| rhTPO arm | Experimental | rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)
Concurrent Chemoradiotherapy:
Radiation: judged according to the tumor site and radiotherapy purpose.
Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7)
Raltitrexed: 3 mg/m2 q3w Receives: Drug: rhTPO; Drug: irinotecan; Drug: Raltitrexed; Radiation: radiotherapy |
| rhIL-11 arm | Active comparator | rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)
Concurrent Chemoradiotherapy:
Radiation: judged according to the tumor site and radiotherapy purpose.
Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7)
Raltitrexed: 3 mg/m2 q3w Receives: Drug: irinotecan; Drug: Raltitrexed; Radiation: radiotherapy; Drug: rhIL-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recovery of platelet accounts
Measured: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
the duration after returning to normal
Measured: From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
Secondary outcomes (4)
cycles of concurrent chemotherapy patients received during radiotherapy
Measured: through chemoradiation, an average of 5 weeks
change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30
Measured: at the beginning and the end of chemoradiation.
change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire
Measured: at the beginning and the end of chemoradiation.
the rate of pathological complete response.
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Measured: Surgery scheduled 6-8 weeks after the end of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ji, Fudan University
- Investigators
- Zhen Zhang, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823079
- Sponsor's protocol ID
- FDRT-009
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03823079
- Acronym / sponsor ID
- FDRT-009
- Conditions
- Recurrent Colorectal Carcinoma, Thrombopenia
- Keywords
- Recombinant human interleukin-11, Recombinant human thrombopoietin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.
Detailed description
Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil. Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay. On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation. Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy. This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTPO arm | Experimental | Drug: rhTPO, Drug: irinotecan, Drug: Raltitrexed, Radiation: radiotherapyrhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7) Raltitrexed: 3 mg/m2 q3w |
| rhIL-11 arm | Active comparator | Drug: irinotecan, Drug: Raltitrexed, Radiation: radiotherapy, Drug: rhIL-11rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1*28 6/6) or 65 mg/m2 (UGT1A1*28 6/7) Raltitrexed: 3 mg/m2 q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The primary tumor is colorectal cancer, histologically proved recurrence or metastasis disease, or pelvic relapse within 6 months after oxaliplatin-based adjuvant chemotherapy.
- Not suitable for re-use of oxaliplatin and fluorouracil.
- No medication history of irinotecan.
- Lesions evaluable, and has indications for radiotherapy.
- UGT1A1*28 gene phenotype is 6/6 or 6/7
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women
- Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPOrhTPO 300u/kg, subcutaneous injection, qd | Drug | rhTPO arm |
| irinotecan80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) | Drug | rhIL-11 arm, rhTPO arm |
| Raltitrexed3mg/m2 q3w | Drug | rhIL-11 arm, rhTPO arm |
| radiotherapyin the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose. | Radiation | rhIL-11 arm, rhTPO arm |
| rhIL-11rhIL-11 50ug/kg, subcutaneous injection, qd | Drug | rhIL-11 arm |
Primary outcome
the rate of recovery of platelet accounts
Time frame: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
the duration after returning to normal
Time frame: From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
4 secondary outcomes
cycles of concurrent chemotherapy patients received during radiotherapy
Time frame: through chemoradiation, an average of 5 weeks
change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30
Time frame: at the beginning and the end of chemoradiation.
change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire
Time frame: at the beginning and the end of chemoradiation.
the rate of pathological complete response.
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Zhang, MD study chair
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhTPO, irinotecan and Raltitrexed in people with Recurrent Colorectal Carcinoma and Thrombopenia, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Zhu, MD (+86-2164175590 ext. 81607, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of recovery of platelet accounts (time frame: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.